Amgen and Novartis have announced promising results from a Phase III clinical trial of an injectable new migraine drug called Aimovig (erenumab).
In a study of 246 patients with episodic migraine, significantly more patients injected with Aimovig had at least a 50 percent reduction in the number of monthly migraine days compared to a placebo. The study was the first of its kind to include hard-to-treat patients who have tried and failed at least two other migraine medications due to lack of efficacy or intolerable side effects.
"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said Sean Harper, MD, executive vice president of Research and Development at Amgen.
"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig.”
Aimovig belongs to a new class of medication – known as fully human monoclonal antibodies -- that target and block receptors in the brain where migraines are thought to originate. It is designed to be administered once a month with a self-injection device for migraine prevention.
"The results add to the consistent body of evidence for erenumab (Aimovig) across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis.
“We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."
Amgen and Novartis expect the Food and Drug Administration to make a decision on Aimovig in May. The two companies will share sales rights to Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize it in Europe and the rest of world.
Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.
About half of people living with migraine are undiagnosed. Current medications to prevent migraines have been repurposed from other medical conditions, and are often associated with poor results.